A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning

Not Applicable

Recruiting

• Conditions: Fibrous Histiocytoma; Osteosarcoma; Sarcoma, Ewing; Fibrosarcoma; Chondrosarcoma
• Interventions: Diagnostic Test: CT/MRI; Device: 3D Printed Anatomic Model

• Registration Number: NCT06387485
• Lead Sponsor: Ricoh USA, Inc.

Brief Summary

This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.

Primary endpoint: Operative time of surgical procedure.

Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.

Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29
• Primary Completion: 2024-12-31
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subjects must be at least 22 years of age.
2. Subjects must have the ability to provide written informed consent.
3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.

Exclusion Criteria

1. Pregnant or nursing women.
2. Subjects that have a serious systemic pathology.
3. Subjects that have clotting disorders.
4. Subjects that have uncontrolled hypertension.
5. Subjects that are HIV-positive.
6. Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.
7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Imaging	CT/MRI	Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model
3D Printed Anatomic Model	3D Printed Anatomic Model	Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).
3D Printed Anatomic Model	CT/MRI	Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).

Primary Outcome Measures

Name	Time	Method
Operative time	Incision to closure	Operative time of surgical procedure based on incision and closure time

Secondary Outcome Measures

Name	Time	Method
Tumor margin status	Post-surgery (+3 days)	The proportion of negative tumor margins as determined by laboratory analysis.
Blood loss	Incision to closure	Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL.
Adverse Events	Surgery to 90 days post-surgery	The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review.

Trial Locations

Locations (2)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

William Beaumont University Hospital; 🇺🇸 Royal Oak, Michigan, United States